Biweekly Gemcitabine-Oxaliplatin and Dexamethasone for Relapsed/Refractory Malignant Lymphoma

Lymphoma Clinical Trial

Official title:

Biweekly Gemcitabine-Oxaliplatin and Dexamethasone for Relapsed/Refractory Malignant Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00561301
• Other study ID #: C-012A
• Status: Recruiting
• Phase: Phase 2
• First received: November 18, 2007
• Last updated: November 18, 2007
• Start date: November 2006
• Est. completion date: October 2009

Study information

• Verified date: November 2007
• Source: Cooperative Study Group A for Hematology
• Contact: Yae Eun Jang
• Phone: 82-2-3010-7290
• Email: redpin75[@]paran.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

- To evaluate the feasibility of combination chemotherapies comprising of gemcitabine-dexamethasone-oxaliplatin for patients with refractory or relapsed malignant non-Hodgkin lymphoma (NHL)

Description:

- The feasibility will be evaluated in terms of objective response rate, efficacy of stem cell collection, disease-free survival, and overall survival.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients who have refractory to first-line CHOP-like regimen

• Patients who have first relapse after

• first-line CHOP-like regimen

• upfront autologous or allogeneic hematopoietic stem cell transplantation

• Age 15 years or more

• ECOG performance status = 2

• Adequate bone marrow function

• Adequate kidney,liver,cardiac

Exclusion Criteria:

• Patients who have received GEM or OX

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• GemDOx
gemcitabine oxliplatin

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Cooperative Study Group A for Hematology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate		10/2009
Secondary	toxicities, progression-free survival, overall survival, ASCC efficacy, rate for proceeding to ASCT		10/2009